Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial (GABA)

Women having abortion procedures between 15 weeks 0 days and 23 weeks 6 days gestational age on the day of their procedure commonly have dilators placed in their cervix overnight before the abortion procedure. The dilators are put in during a pelvic exam in the clinic and after women go home they expand slowly overnight to open the cervix before the abortion procedure the next day. This can be a painful experience and health care providers often give women different kinds of pain medicine to help them.

The investigators are interested in whether a medicine called gabapentin, which is a non-narcotic medicine, could help. Gabapentin is approved by the U.S. Food and Drug Administration (FDA) for prevention of seizures and for treating nerve pain and doctors are also using it to decrease pain for people having surgical procedures.

The main goals of our study are to learn about:

1. Women's pain experience with dilators in their cervix overnight before the abortion procedure
2. How well gabapentin works to decrease women's pain while they have the dilators in their cervix

Women who enroll in the study will get a dose of either gabapentin or placebo (a pill with no medicine in it) before their dilators are placed in the clinic. The medication they get (gabapentin or placebo) will be chosen by chance, like flipping a coin. Neither the women in the study nor the doctors giving them the medication will know which medication they receive so the investigators can learn about their pain without being influenced by knowing which medication they take. Doctors will be able to find out which medication women got if there is an emergency or if it changes their medical care.

The investigators will communicate with women in real time overnight by text messaging to see how much pain they are having in the moment and how much pain medicine they are taking.

The investigators hypothesize that women who receive gabapentin will have a smaller increase in their pain with the dilators than women who receive placebo (a pill with no medicine in it).

The investigators' findings will help doctors understand women's pain experience with dilators better and possibly provide a new way of treating pain with gabapentin.

Study Overview

• Status: Completed
• Conditions: Pain; Abortion, Induced; Cervical Preparation
• Intervention / Treatment: Drug: Gabapentin 600mg; Drug: acetaminophen/codeine and ibuprofen; Drug: Placebo oral capsule

Detailed Description

The investigators have planned a double-blind randomized controlled trial of repeated doses of gabapentin compared to placebo for pain management during the time after dilator insertion and prior to D&E the subsequent day.

• Participants will receive gabapentin 600 mg or placebo prior to dilator insertion
• Pain scores will be measured via numeric rating scale (NRS) at baseline and 5 minutes after last dilator insertion while the participant is in clinic
• Additional pain scores, side effects (specifically dizziness and sedation), and additional analgesic use will be obtained by text message while the patient is home at 2 hours, 4 hours, and 8 hours after time of dilator insertion
• Subjects will take a second dose of study drug (either gabapentin 600 mg or placebo, concordant with their initial medication) at 8 hours after their first dose
• Final pain score, side effect, and analgesic use assessment will occur upon presentation to the pre-operative are for D&E the subsequent day

There will be no change in standard insertion of osmotic dilators (hygroscopic dilators only with Lidocaine 20mL cervical anesthesia), or provision of home analgesic medications (ibuprofen and acetaminophen with codeine in our practice).

The investigators hypothesize that women who receive gabapentin will report a smaller increase in pain from baseline at 8 hours after dilator placement compared to women receiving placebo.

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 15 weeks 0 days gestational age - 23 weeks 5 days gestational age at time of dilator insertion
• Able to read and write in English
• Active cell phone with text messaging capability
• Ride home from dilator insertion clinic appointment

Exclusion Criteria:

• Current use of gabapentin or pregabalin
• Allergy to gabapentin, acetaminophen, codeine, or ibuprofen
• Self reported renal disease (severe impaired renal function)
• Self reported current or chronic narcotic use (typical daily use)
• Women with any issue that, in the opinion of the investigator, would interfere with study participation or generating accurate study data

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gabapentin; Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home) Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight	Drug: Gabapentin 600mg; Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place); Other Names: Neurontin; Drug: acetaminophen/codeine and ibuprofen; Over the counter analgesic medications; Other Names: Advil; Tylenol-Codeine No. 3
Placebo Comparator: Placebo oral capsule; Matched placebo Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight	Drug: acetaminophen/codeine and ibuprofen; Over the counter analgesic medications; Other Names: Advil; Tylenol-Codeine No. 3; Drug: Placebo oral capsule; Packaged identical to gabapentin dosing; Other Names: Carboxymethyl cellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in NRS Pain Score at 8 Hours After Dilator Insertion	Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message.	8 hours after insertion of last osmotic dilator

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in NRS Pain Score at 5 Minutes After Last Dilator Insertion	Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained in person before subject leaves clinic appointment.	5 minutes after insertion of last osmotic dilator
Mean Change From Baseline in NRS Pain Score at 2 Hours After Dilator Insertion	Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message.	2 hours after insertion of last osmotic dilator
Mean Change From Baseline in NRS Pain Score at 4 Hours After Dilator Insertion	Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message.	4 hours after insertion of last osmotic dilator
Mean Change From Baseline in NRS Pain Score at Time of Presentation for D&E Procedure (Day Following Dilator Insertion)	Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained in person upon presentation for D&E procedure.	Time of presentation for D&E (day after dilator insertion)
Number of Participants Using Narcotic Pain Medication (Acetaminophen/Codeine)	Subject account of how many used acetaminophen/codeine (standard medications given for supplement NSAID as needed after dilator insertion)	Collected between each subject contact (2 hours, 4 hours, 8 hours after dilator insertion and at time of presentation for D&E procedure)

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: Society of Family Planning
• Investigators: Study Director: Mitchell Creinin, MD, University of California, Davis; Principal Investigator: Natasha Schimmoeller, MD, MPH, MA, University of California, Davis

Publications and helpful links

General Publications

• Yan PZ, Butler PM, Kurowski D, Perloff MD. Beyond neuropathic pain: gabapentin use in cancer pain and perioperative pain. Clin J Pain. 2014 Jul;30(7):613-29. doi: 10.1097/AJP.0000000000000014.
• Rose MA, Kam PC. Gabapentin: pharmacology and its use in pain management. Anaesthesia. 2002 May;57(5):451-62. doi: 10.1046/j.0003-2409.2001.02399.x.
• Mercier RJ, Liberty A. Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial. Contraception. 2014 Dec;90(6):594-600. doi: 10.1016/j.contraception.2014.07.008. Epub 2014 Jul 23.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2017
• Primary Completion (Actual): November 5, 2018
• Study Completion (Actual): November 5, 2018

Study Registration Dates

• First Submitted: March 9, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 15, 2017

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Gabapentin; Abortion; Text message; Osmotic dilators
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Gastrointestinal Agents; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Respiratory System Agents; Antitussive Agents; Laxatives; Gabapentin; Acetaminophen; Ibuprofen; Codeine; Carboxymethylcellulose Sodium
• Other Study ID Numbers: 987072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No